§5.4 ". . . under Section 402(f) unless it meets on of the following . . ."

• Jurisdiction: United States
• Publication year: 2022

§5.4 ". . . under Section 402(f) unless it meets on of the following . . ."

This phrase defines adulteration for a dietary supplement containing a new dietary ingredient. Because the dietary supplement contains a new dietary ingredient, it is automatically assumed to be adulterated under Section 402(f) of the amended '38 Act.⁵⁹ However, manufacturers can overcome the assumption of adulteration by satisfying one of two scenarios.⁶⁰

Section 402(f) was added by DSHEA to include the circumstances when a dietary supplement is adulterated. The section is entitled "Safety of Dietary Supplements and Burden of Proof on FDA."⁶¹ The section is inclusive for dietary supplements comprising old ingredients and dietary supplements containing new dietary ingredients. Section 402(f)(1)(B) is specific for supplements containing new dietary ingredients, stating such supplements shall be adulterated when ". . . there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury."⁶²

The report accompanying S. 784 stated that the FDA had disregarded Congressional intent by attempting to regulate food in a ". . . resulted-oriented effort to impede the manufacture and sale of dietary supplements . . ."⁶³ To correct what was seen as abuse, the committee⁶⁴ set forth four situations when a dietary supplement would be deemed adulterated.⁶⁵ The FDA can declare a dietary supplement where it is shown the supplement is a "substantial and unreasonable risk of illness or injury . . ."⁶⁶ It is important to note that in the report, Congress used the phrase "substantial and unreasonable" as opposed to "substantial or unreasonable" as in the provision.⁶⁷ To prove adulteration under the provision, the burden of proof was on the FDA to satisfy by a "preponderance of the evidence."⁶⁸ If a proceeding is brought under the provision, judicial review should be on a de novo basis.⁶⁹

In one case, an issue presented was whether the FDA was correct in its assertion that "unreasonable" under DSHEA requires a risk-benefit analysis.⁷⁰ The issue related to the risks presented by dietary supplements containing ephedrine alkaloid compounds. In holding that "unreasonable" as used under DSHEA did not call for a risk-benefit analysis, the court indicated the FDA's assertion would place a burden on manufacturers of the supplements.⁷¹ This was clearly against Congressional intent as the court quoted from the provision:

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